GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, has announced the completion of key manufacturing, regulatory, clinical, and preclinical milestones for its GEO-MVA vaccine program. These milestones are critical for the initiation of the pivotal Phase 3 immune-bridging study, scheduled to begin in the fourth quarter of 2026.
The completion of these milestones marks a significant inflection point for the GEO-MVA program, according to David A. Dodd, Chairman and Chief Executive Officer of GeoVax. "We have systematically executed the manufacturing, regulatory, clinical and scientific activities required to support successful study completion, preparing for regulatory registration and ultimate commercialization," Dodd said.
One notable achievement is the completion of a comparative nonclinical immunogenicity study evaluating GEO-MVA alongside the licensed MVA vaccine, Imvanex®. The study demonstrated that GEO-MVA generated robust orthopoxvirus-specific immune responses, including neutralizing antibodies, which strengthens confidence in the vaccine's potential. This data supports the planned immune-bridging strategy, which will compare GEO-MVA's immune responses to those of the licensed MVA-BN vaccine in a 500-participant study.
Manufacturing readiness has been achieved with the successful production, filling, packaging, and release of GMP clinical product for the pivotal study. Regulatory alignment has been established through EMA Scientific Advice, endorsing an expedited immune-bridging pathway. Clinical operations are advanced with CRO engagement and site identification, targeting study initiation in Q4 2026. Additionally, preclinical data and commercial planning efforts, including discussions with government agencies, are underway.
GeoVax expects to report results from the Phase 3 study in mid-2027. The company believes these milestones have substantially de-risked the GEO-MVA program, positioning it for advancement. GEO-MVA is being developed to expand global manufacturing capacity for non-replicating MVA vaccines, addressing critical needs for mpox and smallpox preparedness.
For more information on GeoVax and its programs, visit GeoVax's website. The company also provided a video with additional CEO commentary, available on YouTube.
